CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Enlicitide Chloridedrug
Likely dose
Enlicitide Chloride 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05070390
NCT05070390Phase 1Completed

An Open-Label Clinical Study to Evaluate the Pharmacokinetics of MK-0616 Following Administration of a Single Dose to Participants With Moderate Renal Impairment

Merck Sharp & Dohme LLC·interventional·Posted Oct 7, 2021·Updated Sep 26, 2024

In Brief

A Phase 1 clinical trial evaluating Enlicitide Chloride for Moderate Renal Impairment. Completed, enrolled 18 participants across 2 sites.

Detailed Summary

This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and \<60milliliter/minute/1.73meters\^2 (ml/min/1.73m\^2). There is no formal hypothesis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedOct 7, 2021
Enrollment StartNov 16, 2021
Primary CompletionMay 3, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.7 years ago

Interventions

Enlicitide Chloridedrug

10 mg capsule administered orally